$172,000.

00 life insurance, paid time off United States, Georgia, Atlanta Jun 26, 2026

Department:

107000

Regulatory Location:

San Diego, USA

Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients.

Our work is rewarding

both professionally and personally
because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission
to identify, develop and deliver life-changing therapies to people living with rare disease.

We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Position Summary:

The Senior Manager, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for biologic products, with a strong focus on late-stage development, Phase 3 programs, and rare disease therapeutics. The Senior Manager serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Technical Operations, Process Development, Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with global regulatory requirements and business objectives. This position requires extensive experience supporting biologics development programs and a strong technical understanding of biologic drug substance and drug product manufacturing, analytical characterization, process development, comparability, and control strategies. The individual will be responsible for driving CMC regulatory submissions, managing Health Authority interactions related to CMC topics, assessing regulatory risks, and supporting successful product approvals and post-approval activities worldwide.

Responsibilities:

CMC Regulatory Strategy, Submissions & Dossier Development Develop and implement global CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of biologic products.\nServe as the CMC Regulatory lead on cross-functional program teams, providing strategic regulatory guidance throughout product development.\nAssess regulatory risks, develop mitigation strategies, and provide regulatory recommendations to support program goals and business priorities.\nContribute to regulatory strategy development for expedited development programs, orphan drug products, and rare disease indications.\nLead preparation, review, and submission of CMC documentation for global regulatory filings, including INDs, IMPDs, CTAs, BLAs, NDAs, MAAs, amendments, supplements, variations, and annual reports.\nAuthor and review Module 2 and Module 3 content and ensure consistency across submission components.\nCoordinate cross-functional contributions to CMC regulatory submissions and ensure compliance with global regulatory requirements and submission standards.\nSupport preparation for major registration milestones, including first marketing applications and global expansion filings.\nLead CMC-related Health Authority interactions and support agency meetings globally.\nSupport inspection readiness and regulatory assessments related to manufacturing and product quality.\nDevelop global regulatory filing strategies for lifecycle management activities and post-approval CMC changes, including manufacturing process changes, analytical method updates, specification revisions, site transfers, process validation, and comparability assessments. Technical Leadership for Biologics Development Provide regulatory guidance and strategic input for biologics development programs, including monoclonal antibodies (mAbs), recombinant proteins, fusion proteins, and other complex biologic modalities.\nCollaborate with development and manufacturing teams to support regulatory strategies related to cell line development, upstream and downstream process development, scale-up, process validation, and commercial manufacturing.\nEvaluate regulatory impact of manufacturing changes involving microbial and mammalian cell culture processes, purification operations, formulation development, fill-finish activities, and technology transfers.\nSupport development and regulatory assessment of comparability strategies for manufacturing process changes, site transfers, process improvements, and lifecycle management activities.\nProvide regulatory oversight and strategic guidance for analytical characterization programs and control strategies supporting product quality, safety, and efficacy.\nContribute to regulatory assessment of critical quality attributes (CQAs), process parameters, control strategies, and product characterization data throughout development and commercialization.

Education/Experience Requirements:

Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required. Equivalent combination of education and applicable job experience may be considered.\nAdvanced degree (MS, PharmD, PhD, or equivalent) preferred.\n7+ years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry, including significant CMC Regulatory Affairs experience.\nDemonstrated experience supporting biologics development programs from early development through commercialization.\nSignificant experience supporting Phase 3 and late-stage development programs.\nExperience supporting global regulatory submissions, including BLAs, MAAs, NDAs, INDs, IMPDs, and CTAs.\nExtensive experience leading CMC regulatory activities for biologic products, particularly monoclonal antibodies, recombinant proteins, and other therapeutic biologics.\nExperience supporting manufacturing process development and commercialization of biologic drug substances and drug products.\nExperience participating in and leading Health Authority interactions related to CMC topics.\nExperience supporting global post-approval change management, comparability assessments, process validation, and lifecycle management activities.

Additional Skills/Experience/Requirements:

The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.\nComprehensive understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC regulatory requirements.\nStrong understanding of biologics regulatory requirements throughout product development and commercialization.\nExperience supporting products for rare diseases and/or orphan indications preferred.\nDemonstrated ability to develop and execute global CMC regulatory strategies.\nStrong knowledge of CMC development, process validation, comparability, quality systems, and lifecycle management requirements.\nStrong technical understanding of biologics drug substance manufacturing processes and downstream processing and purification technologies.\nStrong understanding of biologic drug product development including analytical methods and characterization techniques used for biologics.\nStrong understanding of critical quality attributes (CQAs), quality target product profiles (QTPPs), control strategies, and analytical comparability principles for monoclonal antibodies and recombinant protein therapeutics.\nAbility to travel up to 10% domestically and internationally.\nAll positions have an essential job function to be able to perform face-to-face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings:

\nTravere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.

Benefits:

Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation:

Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range:

$132,000.00

$172,000.00
This information is current as of the date of this posting and may be modified in the future.

Actual pay offered to a candidate will depend on a variety of factors including the candidate's experience, education, skills, and location. Travere will accept applications on an ongoing basis until a candidate is selected for the position. Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disability Employer. If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. 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Senior Manager, CMC Regulatory Affairs (Biologics)